BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD).
BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors…
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on Enhancing Patient Engagement Efforts Across the Food and Drug Administration.
BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II.
BIO supports the approach described in the…
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports.
BIO appreciates the effort to categorize listed annual reportable…
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.
The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k)…
BIO submitted comments on Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration (FDA).
BIO is committed to promoting a regulatory environment that continues to support and incentivize the biopharmaceutical ecosystem. Minimizing the regulatory…
BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making.
The benefit-risk framework is an important advancement in FDA product regulation because it reflects and reinforces the fact the FDA review process is grounded…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document.
The draft guidance provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents…
Amicus Brief | April 22, 2019 | Intellectual Property, Diagnostics